Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
clopidogrel bisulfate (UNII: 08I79HTP27) (clopidogrel - UNII:A74586SNO7)
Cardinal Health
clopidogrel bisulfate
clopidogrel 75 mg
PRESCRIPTION DRUG
New Drug Application
PLAVIX- CLOPIDOGREL BISULFATE TABLET, FILM COATED CARDINAL HEALTH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PLAVIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLAVIX. PLAVIX (CLOPIDOGREL BISULFATE) TABLETS INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED EFFECTIVENESS IN POOR METABOLIZERS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. EFFECTIVENESS OF PLAVIX DEPENDS ON ACTIVATION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1) POOR METABOLIZERS TREATED WITH PLAVIX AT RECOMMENDED DOSES EXHIBIT HIGHER CARDIOVASCULAR EVENT RATES FOLLOWING ACUTE CORONARY SYNDROME (ACS) OR PERCUTANEOUS CORONARY INTERVENTION (PCI) THAN PATIENTS WITH NORMAL CYP2C19 FUNCTION. (12.5) TESTS ARE AVAILABLE TO IDENTIFY A PATIENT'S CYP2C19 GENOTYPE AND CAN BE USED AS AN AID IN DETERMINING THERAPEUTIC STRATEGY. (12.5) CONSIDER ALTERNATIVE TREATMENT OR TREATMENT STRATEGIES IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (2.3, 5.1) RECENT MAJOR CHANGES Boxed Warning 03/2010 Dosage and Administration (2.3, 2.4) 08/2010 Warnings and Precautions (5.1, 5.2, 5.3) 08/2010 INDICATIONS AND USAGE Plavix is a P2Y platelet inhibitor indicated for: Acute coronary syndrome Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2) DOSAGE AND ADMINISTRATION Acute coronary syndrome (2.1) Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 75 mg, 300 mg (3) CONTRAINDICATIONS Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage (4.1) Hypersensitivity to clopidogrel or any component of the product (4.2) WARNINGS AND PRECAUTIONS Reduced effectiveness in impaired CYP2C19 function: Avoid concomitant use with drugs that are strong or moderate Прочитать полный документ